(34 days)
The ACON® Test Device is a rapid Strep A Rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.
The ACON® Strep A Rapid Test Device is a rapid Strep A Rapid chromatographic immunoassay.
This looks like a 510(k) clearance letter for the ACON® Strep A Rapid Test Device, not a typical study report with detailed acceptance criteria and performance data. The letter confirms that the device has been found substantially equivalent to a legally marketed predicate device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for this specific device's study is not directly available in the provided text.
Here's a breakdown of what can be inferred or stated based on the document and the nature of 510(k) submissions:
What can be inferred from the document:
- Device: ACON® Strep A Rapid Test Device
- Intended Use: "a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only."
- Regulatory Pathway: 510(k) substantial equivalence. This means the device's performance was compared to a predicate device that was already legally marketed. The acceptance criteria would typically involve demonstrating comparable performance (sensitivity, specificity, accuracy) to that predicate.
What is NOT provided in the document:
The document does not contain the detailed study report that would specify:
- A table of acceptance criteria and the reported device performance: This information would be in the actual study submission, often a substantial equivalence report, which is not this letter. For rapid diagnostic tests like this, acceptance criteria would typically include thresholds for sensitivity and specificity compared to a reference method (e.g., bacterial culture).
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. For Strep A tests, the 'ground truth' is usually bacterial culture results from the same patient sample, not expert interpretation of the rapid test itself.
- Adjudication method for the test set: Not applicable in the context of a lab test where the ground truth is often an objective lab result (culture).
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a rapid diagnostic test, not an AI imaging or diagnostic algorithm requiring human reader interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone diagnostic kit. Its performance is its "standalone" performance.
- The type of ground truth used: While not explicitly stated, for Strep A rapid tests, the gold standard (ground truth) is almost always a bacterial culture of the throat swab specimen.
- The sample size for the training set: Not applicable for a rapid immunoassay kit. There isn't an "algorithm" being trained in the conventional machine learning sense. The device is a chemical/biological system.
- How the ground truth for the training set was established: Not applicable.
Summary based on available information:
| Category | Information from Document / Inferred |
|---|---|
| 1. Table of Acceptance Criteria & Device Performance | Not provided in this document. The full 510(k) submission would contain this. Based on the nature of the device, typical acceptance criteria would involve demonstrating comparable clinical sensitivity and specificity to a legally marketed predicate device, usually against a bacterial culture as the gold standard. |
| 2. Test Set Sample Size & Data Provenance | Not provided. |
| 3. Ground Truth Experts & Qualifications | Not applicable in the sense of expert interpretation creating the ground truth. For Strep A tests, the ground truth is typically established by an objective laboratory method (bacterial culture). |
| 4. Adjudication Method | Not applicable for this type of diagnostic test where a clear, objective ground truth (bacterial culture) is used. |
| 5. MRMC Comparative Effectiveness Study & Effect Size | Not applicable. This is a rapid diagnostic immunoassay, not an AI-assisted diagnostic or imaging device requiring human-in-the-loop studies. |
| 6. Standalone Performance Study | Yes, the performance reported in the 510(k) to meet substantial equivalence would be the standalone performance of the ACON® Strep A Rapid Test Device itself. (Details not in this letter). |
| 7. Type of Ground Truth Used | Inferred: Bacterial Culture. For Strep A rapid antigen detection tests, bacterial culture is the generally accepted gold standard for confirming Group A Streptococcus infection from throat swabs. |
| 8. Training Set Sample Size | Not applicable in the conventional machine learning sense for a rapid immunoassay kit. The device is a biochemical test, not an algorithm that undergoes "training." Its performance is inherent in its design and manufacturing. |
| 9. How Ground Truth for Training Set was Established | Not applicable for this type of device. The "training" of such a device relates to its development and optimization, for which reference methods (like culture) would be used, but not in the sense of a machine learning training set with distinct ground truth labeling. The validation of the device uses samples where ground truth is established by culture. |
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.